A Study of MA-0217 (ASP1128) in Healthy Adult Subjects and Healthy Elderly Subjects

Phase 1 Completed 102 enrolled Astellas Pharma Europe B.V.

RandomizedSequentialDouble-blindBasic science

Summary

The primary purpose of this study is to evaluate the safety and tolerability of single ascending intravenous doses of ASP1128 in healthy adult male and female subjects and multiple ascending intravenous doses of ASP1128 in healthy adult male and female subjects and healthy elderly male and female subjects. This study will also evaluate the pharmacokinetics and the effect on the QT interval using Fridericia's correction formula (QTcF) in these subjects.

Timeline

Start: 2017-11-20
Primary completion: 2018-09-07
Completion: 2018-09-07

Publications

Taniuchi Y, van Till JWO, Wojtkowski T, Toyoshima J, Koibuchi A, Sargent B, Han D. Single- and Multiple-dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP1128, a Novel Peroxisome Proliferator-activated Receptor delta Modulator, in Healthy Participants. Clin Pharmacol Drug Dev. 2023 Aug;12(8):810-818. doi: 10.1002/cpdd.1236. Epub 2023 Mar 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP1128	Unknown	0.3 mg	Intravenous
Subject	ASP1128	Unknown	3 mg	Intravenous
Subject	ASP1128	Unknown	10 mg	Intravenous
Subject	ASP1128	Unknown	30 mg	Intravenous
Subject	ASP1128	Unknown	100 mg	Intravenous

Indications

No indication recorded.